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<|newrecord|> nctId: NCT06273020 id: MI22-00013 briefTitle: Effect of Cerebrolysin on the Blood Brain Barrier in Patients With Diabetes and Ischemic Stroke overallStatus: RECRUITING date: 2022-11-17 date: 2024-11 date: 2024-12 date: 2024-02-22 date: 2024-02-22 name: Hospital Universitario Dr. Jose E. Gonzalez class: OTHER name: Ever Neuro Pharma GmbH briefSummary: A prospective, single-center study would be carried out in the Neurology Department of the University Hospital "Dr. José Eleuterio González" in order to analyze the effect of cerebrolysin on the blood-brain-barrier in patients with ischemic stroke with personal history of type-2 diabetes conditions: Ischemic Stroke, Acute conditions: Diabetes Mellitus, Type 2 conditions: Blood Brain Barrier studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: There are 3 groups in this clinical trial
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Group 1: 20 patients with previous intravenous thrombolysis (IVT) in the qualifying stroke and who agreed to receive and got selected (through randomization) cerebrolysin.
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Group 2 : 20 patients with previous IVT in the qualifying stroke and who agreed to receive cerebrolysin but they were not choose through randomization.
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Group 3: 20 patients that they were not candidates to receive IVT (out of therapeutic window) but agreed to receive cerebrolysin (randomization not used) primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 60 type: ESTIMATED name: Cerebrolysin name: Brain-MRI with contrast after 10-14 days of cerebrolysin measure: Blood-Brain-Barrier Permeability after 10-14days of cerebrolysin in patients with AIS of the middle cerebral artery measure: Comparison of clinical severity, using NIH Stroke Scale in patients with and withouth cerebrolysin measure: Comparison of functional prognosis, using modified Rankin scale in patients with and withouth cerebrolysin measure: Comparison of cognitive impairment, using Montreal Cognitive Assessment in patients with and withouth cerebrolysin sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Servicio de Neurología del Hospital Universitario "Dr.José E. González" status: RECRUITING city: Nuevo León state: Monterrey zip: 64020 country: Mexico name: Servicio F de Neurología del Hospital Universitario "Dr.José E. González" role: CONTACT phone: +528183591111 email: [email protected] name: José C Becerra-Cruz, M.D. role: CONTACT phone: +522324393970 email: [email protected] hasResults: False
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<|newrecord|> nctId: NCT06273007 id: EFP_2023_02_19 briefTitle: Improving Intrapartum Care for Saving Life at Birth in Ethiopia Through PartoMa Approach acronym: PartoMa-Eth overallStatus: RECRUITING date: 2023-06-01 date: 2025-12-31 date: 2027-12-31 date: 2024-02-22 date: 2024-02-22 name: Haramaya Unversity class: OTHER name: University of Copenhagen name: Leiden University Medical Center name: Laerdal Foundation briefSummary: Overall Objective
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To introduce PartoMa approach (locally agreed and achievable intrapartum guidelines and a continual in-house training program) to Ethiopian context through continuous fetal heart rate (FHR) monitoring using MOYO device and co-creation of context specific intrapartum care guideline for improving decision making in intrapartum care in Eastern Ethiopia.
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Interventions
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1. Locally agreed and achievable intrapartum guidelines
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2. Low dose high frequency trainings (LDHF)
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3. Partograph Overall Design
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A quasi-experimental pre-post study (PartoMa study)
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Setting
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Department of Obstetrics and Gynaecology Haramaya Hospital and Hiwot Fana University Hospital, Ethiopia.
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Population
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Laboring women delivering at the study site from February 2023 to March 2025 and their offspring, as well as health providers. Women and their offspring will be enrolled at/after onset of labour and followed until discharge.
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Endpoints
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The primary endpoint is perinatal mortality. For further description and secondary outcomes, please see below.
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Study Time
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Data collection from June 2023 to May 2025.
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Specific Objectives i. To assess FHR monitoring practice and use of obstetric guideline for decision making in Hiwot Fana University Hospital ii. To improve feto-maternal outcome through applying PartoMa approach in Hiwot Fana University Hospital.
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iii. To determine the feasibility, acceptability and sustainability of low-dose high frequency trainings and PartoMa seminars in Hiwot Fana University Hospital.
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iv. To document changes in pregnancy outcomes after the introduction of PartoMa approaches-seminars, low dose high frequency trainings, continuous FHR monitoring and tailored interventions-in Hiwot Fana University Hospital.
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Setting
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PartoMa Ethiopia will be implemented at Haramaya General Hospital and Hiwot Fana Comprehensive Specialized University Hospital, which are both busy maternity units in Eastern Ethiopia. Both are government hospitals with an annual delivery number of around 5,000. conditions: Stillbirth conditions: Obstetric Complication conditions: Maternal Death conditions: Perinatal Death conditions: Perinatal Morbidity studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 500 type: ESTIMATED name: PartoMa intervention(Locally achievable intrapartum care guideline), in house LDHF trainings measure: stillbirth measure: Birth Asphyxia measure: Maternal death measure: Cesarean sections and vacuum extractions measure: Process indicators of quality of intrapartum care measure: Birth attendant's perception of their work condition in the labour and delivery rooms measure: The women's experience of care received during delivery. sex: FEMALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Haramaya Hospital status: RECRUITING city: Harar state: Oromia country: Ethiopia name: Roba Ararsa, MD role: CONTACT lat: 9.31387 lon: 42.11815 facility: Hiwot Fana University Hospital status: NOT_YET_RECRUITING city: Harar country: Ethiopia name: Redwan Ahmed, MD role: CONTACT lat: 9.31387 lon: 42.11815 hasResults: False
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<|newrecord|> nctId: NCT06272994 id: 231724 briefTitle: Swab Testing to Optimize Pneumonia Treatment With Empiric Vancomycin acronym: STOP-Vanc overallStatus: ENROLLING_BY_INVITATION date: 2024-04-03 date: 2027-12-01 date: 2027-12-31 date: 2024-02-22 date: 2024-04-08 name: Vanderbilt University Medical Center class: OTHER briefSummary: This is a single center, pragmatic, randomized clinical trial (pRCT) examining whether reporting the results of a negative rapid PCR back to the provider via a pager alert results in decreased vancomycin utilization for critically ill adults with community-acquired pneumonia when compared with usual care. conditions: Community-acquired Pneumonia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This study will be performed as a single center, pragmatic, randomized clinical trial. primaryPurpose: TREATMENT masking: NONE count: 212 type: ESTIMATED name: MRSA Nasal Swab PCR measure: Vancomycin-free hours alive measure: Time Alive off Vancomycin measure: 30-day all-cause mortality sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Vanderbilt University Medical Center city: Nashville state: Tennessee zip: 37232 country: United States lat: 36.16589 lon: -86.78444 hasResults: False
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<|newrecord|> nctId: NCT06272981 id: BWI202308 briefTitle: A Study of the THERMOCOOL SMARTTOUCH Surround Flow (SF) Catheter With the TRUPULSE Generator for Treatment of Drug Refractory Symptomatic PAFOUS acronym: PulseSmart overallStatus: RECRUITING date: 2024-02-28 date: 2025-08-29 date: 2025-08-29 date: 2024-02-22 date: 2024-04-26 name: Biosense Webster, Inc. class: INDUSTRY briefSummary: The purpose of this study is to demonstrate safety and effectiveness of the Biosense Webster (BWI) ablation system (THERMOCOOL SMARTTOUCH surround flow \[STSF\] catheter and TRUPULSE generator) when used for isolation of the atrial pulmonary veins (PVs) in treatment of participants with paroxysmal atrial fibrillation (PAF), an irregular heart rate that causing abnormal blood flow. conditions: Atrial Fibrillation studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 135 type: ESTIMATED name: Pulsed Field (PF) /Radiofrequency (RF) Catheter ablation measure: Number of Participants with Primary Adverse Events (PAEs) measure: Rate of Freedom from Documented (Symptomatic and Asymptomatic) Atrial Arrhythmia (Atrial Fibrillation (AF), Atrial Tachycardia (AT) or Atrial Flutter (AFL) of Unknown Origin) within 91-365 Days Post Index Procedure measure: Change from Baseline in Atrial Fibrillation Effect on Quality of Life (AFEQT) Total Score sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Royal Prince Alfred Hospital status: NOT_YET_RECRUITING city: Camperdown zip: 2050 country: Australia lat: -33.88965 lon: 151.17642 facility: Canberra Heart Rhythm status: RECRUITING city: Garran zip: 2605 country: Australia lat: -35.34206 lon: 149.10846 facility: John Hunter Hospital status: WITHDRAWN city: New Lambton Heights zip: 2305 country: Australia lat: -32.92466 lon: 151.69364 facility: Westmead Hospital status: RECRUITING city: Westmead zip: 2145 country: Australia lat: -33.80383 lon: 150.98768 facility: Southlake Regional Health Centre status: NOT_YET_RECRUITING city: Newmarket state: Ontario zip: L3Y 2P9 country: Canada lat: 44.05011 lon: -79.46631 facility: University of Ottawa Heart Institute status: NOT_YET_RECRUITING city: Ottawa state: Ontario zip: K1Y 4W7 country: Canada lat: 45.41117 lon: -75.69812 facility: Montreal Heart Institute status: NOT_YET_RECRUITING city: Montreal state: Quebec zip: H1T 1C8 country: Canada lat: 45.50884 lon: -73.58781 facility: McGill University Health Centre status: NOT_YET_RECRUITING city: Montreal state: Quebec zip: H3G 1A4 country: Canada lat: 45.50884 lon: -73.58781 hasResults: False
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<|newrecord|> nctId: NCT06272968 id: EA2/252/23 briefTitle: Predicting Cognition After DBS for Parkinson's Disease 2 overallStatus: NOT_YET_RECRUITING date: 2024-02-25 date: 2027-12-01 date: 2030-12-01 date: 2024-02-22 date: 2024-02-22 name: Charite University, Berlin, Germany class: OTHER briefSummary: The aim of the study is to improve estimation of cognitive outcome after STN-DBS in PD in order to avoid risk factors by optimizing peri- and intraoperative management personalize therapeutic strategies for optimal long-term benefit.
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The investigators will test possible predictors (clinical, neuropsychological, neuroimaging, electrophysiological and molecular) for the risk of cognitive dysfunction after deep brain stimulation of the subthalamic nucleus (STN-DBS) in Parkinson's disease (PD) at a single center (Charité - Universitätsmedizin Berlin, Germany). Data collection takes place prior to as well as 3, 12 and 60 months after the STN-DBS operation. Participation is proposed to all PD patients that are planned to undergo STN-DBS after careful examination of eligibility for this treatment according to standard operation procedures. conditions: Cognitive Impairment studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 30 type: ESTIMATED name: Neuropsychological Testing measure: Change in cognitive performance after STN-DBS measure: Incidence of postoperative neurocognitive disorder sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Charité - Universitätsmedizin Berlin city: Berlin zip: 13351 country: Germany lat: 52.52437 lon: 13.41053 hasResults: False
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<|newrecord|> nctId: NCT06272955 id: H-54417 briefTitle: LONG TERM EFFECTS OF SPINAL CORD STIMULATION acronym: SCS for FOG OL overallStatus: ENROLLING_BY_INVITATION date: 2024-01-04 date: 2025-06-30 date: 2025-06-30 date: 2024-02-22 date: 2024-02-22 name: Nora Vanegas class: OTHER briefSummary: Parkinson Disease (PD) patients experience a variety of motor issues such as walking difficulties, loss of balance, and freezing while walking, which impacts their quality of life. Some symptoms, like freezing of gait (FOG), do not respond to medications typically used to treat PD. Current surgical procedures used to alleviate PD symptoms also do not always improve FOG. Since many traditional therapies have failed for the treatment of FOG, researchers have proposed the use of newer treatments. Recent research in animal models and clinical human data using Spinal Cord Stimulation (SCS) has produced promising results, specifically showing improvement in FOG with the use of SCS in patients with PD.
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The purpose of this study is to explore the long-term motor and non-motor effects of SCS in PD patients after completing participation on H-49023. The investigators hypothesize that SCS significantly decreases FOG episodes in patients with PD.
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1. Assess the long-term safety, tolerability and preliminary evidence of effectiveness of upper thoracic spinal cord stimulation for freezing of gait in Parkinson's (PD) patients.
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2. Allowing patients to choose between the two SCS programming paradigms based on their motor, nonmotor and quality of life measures in PD patients with freezing of gait. conditions: Parkinson Disease studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 10 type: ESTIMATED name: Spinal Cord Stimulator (SCS) measure: Safety and Tolerability measure: New Freezing of Gait Questionnaire (NFOG-Q) score measure: Gait and Falls Questionnaire (GFQ) measure: MDS-UPDRS score measure: Timed Up and Go test (TUG) measure: Timed 10-meter walk (T10MW) measure: Mini-Mental State Examination (MMSE) measure: Montreal Cognitive Assessment Scale (MoCA) measure: Beck Depression Inventory (BDI-2) measure: Beck Anxiety Inventory (BAI) measure: Parkinson's Disease Questionnaire - 39 (PDQ39) measure: Non-Motor Symptoms Scale (NMSS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Baylor College of Medicine city: Houston state: Texas zip: 77005 country: United States lat: 29.76328 lon: -95.36327 hasResults: False
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<|newrecord|> nctId: NCT06272942 id: 22722 briefTitle: An Observational Study to Identify New Health Problems Arising After an Intensive Care Unit Admission in People With Acute Respiratory Distress Syndrome in the United States acronym: SeeMe Tool overallStatus: ACTIVE_NOT_RECRUITING date: 2024-01-31 date: 2025-08-30 date: 2025-08-30 date: 2024-02-22 date: 2024-04-23 name: Bayer class: INDUSTRY briefSummary: This is an observational study in which data already collected from people with acute respiratory distress syndrome (ARDS) admitted to an intensive care unit (ICU) are studied.
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ARDS is a life-threatening condition in which fluid builds up in the lungs making breathing difficult.
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In observational studies, only observations are made without participants receiving any advice or any changes to health care.
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People who are admitted to ICU for serious illnesses, like ARDS, often experience new health problems during and after their ICU stays. These health problems that may include physical, mental, and/or emotional disorders, are called post-intensive care syndrome (PICS). Identifying these new health problems early can help people by timely treatments and care.
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In this study, researchers want to identify any health problems that arise after ICU admission in people with ARDS in the United States (US). To do this, researchers will collect information on health problems, treatments, medicines, and healthcare visits in people with ARDS, 1 year before and after an ICU admission.
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They will then look to see whether the health problems are in areas that have been described as the post intensive care syndrome (PICS).
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In addition, they will measure healthcare related costs in the one year after admission and compare it to the one year prior to admission.
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Researchers will also compare this information with data collected for people with pneumonia who did not require ICU admission. This will help them to identify any new health problems arising due to ICU stays.
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The data will come from participants' medical claims information stored in the Optum Clinformatics Data Mart database from 2016 to 2022. The claims data will only be collected for people in the US.
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Researchers will collect data from participants admitted to ICU for ARDS for a maximum of 1 year before and after their stay. conditions: Acute Respiratory Distress Syndrome (ARDS) conditions: Post Intensive Care Syndrome (PICS) studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 140000 type: ESTIMATED name: An ICU admission and a temporally related ARDS diagnosis measure: Morbidity measure: Post ICU Syndrome-related morbidity measure: Incident morbidity measure: Post ICU Syndrome-related incident morbidity measure: Difference in prevalence rates pre versus post index hospitalization measure: Average total healthcare costs based on healthcare billing data in the one year post index ICU admission measure: Exploratory, descriptive difference in ranking of PICS domain comorbidity ratios observed for ARDS (ICU admissions) versus pneumonia (non ICU admissions). sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bayer city: Whippany state: New Jersey zip: 07981 country: United States lat: 40.82454 lon: -74.4171 hasResults: False
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<|newrecord|> nctId: NCT06272929 id: behcet and vascular briefTitle: Serum Elafin and Vascular Affection in Behcet Disease overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-03-01 date: 2025-04-01 date: 2024-02-22 date: 2024-02-22 name: Assiut University class: OTHER briefSummary: To measure the level of serum elafin in patients with BD. To assess the relation between serum elafin levels and disease activity. To evaluate the vascular complications in BD and determine their relationship with disease activity.
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To assess the correlation between serum elafin and vascular affection and their relation with disease activity. conditions: Behcet Disease and Vascular Affection studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 90 type: ESTIMATED name: doppler ultrasound measure: Measuring the level of serum Elafin in patients with BD in comparison to healthy participants. sex: ALL minimumAge: 20 Years maximumAge: 45 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06272916 id: Effect drugs on headache inCS briefTitle: Comparison of the Effect of Aminophylline, Magnesium Sulphate and Placebo in Prevention of Post Dural Puncture Headache in Parturient Undergoing Caesarean Section. overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-04 date: 2025-06 date: 2024-02-22 date: 2024-02-22 name: Assiut University class: OTHER briefSummary: This study will be conducted to better comprehend the effect of aminophylline in comparison to magnesium sulphate on preventing and/or treating PDPH. conditions: Post-Dural Puncture Headache studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 630 type: ESTIMATED name: Aminophylline , magnesium sulphate and placebo measure: Effect of the study drugs on the incidence and severity of PDPH sex: FEMALE minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06272903 id: MBRU IRB-2023-228 briefTitle: Effect of Benzocaine 20% Topical Anesthesia on Pain Levels When Placing Separators in Children Receiving Hall Technique Crowns overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-09 date: 2024-12 date: 2024-02-22 date: 2024-02-22 name: Mohammed Bin Rashid University of Medicine and Health Sciences class: OTHER briefSummary: The goal of this RCT is to investigate the immediate effect of benzocaine 20% topical anesthesia on initial pain and discomfort levels associated with the placement of elastomeric orthodontic separators in children who are receiving Hall Technique crowns on primary molars, among children who have attended the Pediatric Dentistry Department, Dubai Dental Hospital (DDH), Mohammed Bin Rashid University (MBRU) in Dubai, the United Arab Emirates (UAE). conditions: Effect of Benzocaine on Pain studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 32 type: ESTIMATED name: 20% benzocaine, topical anesthetic name: Children's Toothpaste measure: Immediate Pain Levels measure: Patient Satisfaction During Procedure sex: ALL minimumAge: 4 Years maximumAge: 10 Years stdAges: CHILD facility: Mohammed Bin Rashid University Of Medicine and Health Sciences city: Dubai country: United Arab Emirates name: Iyad Hussein role: CONTACT phone: 971564715509 email: [email protected] name: Simran Kaur Sura role: PRINCIPAL_INVESTIGATOR lat: 25.0657 lon: 55.17128 hasResults: False
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<|newrecord|> nctId: NCT06272890 id: GiresunU briefTitle: THE EFFECT OF MOTIVATIONAL INTERVIEWING ON NURSING STUDENTS WITH SOCIAL ANXIETY overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2024-05-20 date: 2024-07-20 date: 2024-02-22 date: 2024-02-22 name: Gazi University class: OTHER briefSummary: Studies support the idea that people diagnosed with social anxiety disorder score significantly lower on self-acceptance than healthy controls, and that self-compassion is inversely related to anxiety. Motivational interviewing has been shown to improve treatment outcomes as well as predict higher self-compassion and reduced resistance among participants.It also has the ability to increase the effectiveness of motivational interviewing as an intervention with perpetrators of intimate partner violence, promoting readiness for change and progression through stages of change. In this context, this study aims to examine the effect of motivational interviewing on social anxiety level, dating violence and self-compassion in nursing students with social anxiety. conditions: Motivation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The research was planned as a randomized controlled experimental study in a two-center parallel group pretest-posttest design. primaryPurpose: OTHER masking: SINGLE maskingDescription: In order to prevent detection bias in the study, all measurements will be made using an online survey form. In order to prevent reporting bias, the data obtained from the research will be coded as A and B by an independent statistician, transferred to the SPSS program and analyzed. whoMasked: OUTCOMES_ASSESSOR count: 58 type: ESTIMATED name: motivational interviewing measure: Motivational interviewing has an effect on nursing students' social anxiety. measure: Motivational interviewing has an effect on nursing students' dating violence. measure: Motivational interviewing has an effect on nursing students' self-compassion. sex: ALL minimumAge: 18 Years maximumAge: 25 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06272877 id: 129944-54 briefTitle: Fluidotherapy in Patients With Distal Radius Fractures overallStatus: RECRUITING date: 2024-02-20 date: 2024-06-20 date: 2024-07-20 date: 2024-02-22 date: 2024-02-22 name: Ahi Evran University Education and Research Hospital class: OTHER briefSummary: Distal radius fractures are the most common fractures when looking at upper extremity fractures. The incidence of distal radius fractures is increasing day by day, and when looking at the databases of various countries, its annual prevalence reaches 70,000 in the UK and 640,000 in the USA. Most of these fractures are related to osteoporosis and require appropriate treatment. If not, it causes loss of work force, permanent disability, and limitation in daily activities.
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Fluidotherapy has also proven to be effective in reducing hand edema in patients with carpal tunnel syndrome and stroke, examining its effect on nerve conduction velocities, and warming hypothermic patients. Compared to these treatment methods, fluid therapy reduces both joint capsule and muscle temperature by 9°C and 5.7°C, respectively. has been reported to increase. conditions: Distal Radius Fractures conditions: Edema Arm conditions: Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomised controlled primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: The Investigator and the outcomes assesor will be different persons. Statician will be different person. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Fluidotherapy name: conventional rehabilitation program measure: Visual analog scale measure: Visual analog scale measure: Visual analog scale measure: Wrist joint range of motion measure: Wrist joint range of motion measure: Wrist joint range of motion measure: Circumference (mm) measure: Circumference (mm) measure: Circumference (mm) measure: Gross Grip Strength: measure: Gross Grip Strength: measure: Gross Grip Strength: measure: Patient-Rated Wrist Evaluation (PRWE) questionnaire measure: Patient-Rated Wrist Evaluation (PRWE) questionnaire measure: Patient-Rated Wrist Evaluation (PRWE) questionnaire sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kirsehir Research and Training Hospital status: RECRUITING city: Kirsehir state: Kişrsehşr zip: 40100 country: Turkey name: Levent Horoz, Asst Prof role: CONTACT phone: :+90 386 280 39 00 email: [email protected] lat: 39.14583 lon: 34.16389 hasResults: False
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<|newrecord|> nctId: NCT06272864 id: BEGIN study briefTitle: BostonGene and Exigent Genomic INsight Study acronym: BEGIN overallStatus: NOT_YET_RECRUITING date: 2024-03-08 date: 2026-01-08 date: 2028-01-08 date: 2024-02-22 date: 2024-02-22 name: BostonGene class: INDUSTRY name: Exigent briefSummary: The BEGIN Study by BostonGene and Exigent Genomic INsight evaluates the efficacy of comprehensive molecular testing in advanced cancer patients. Using the BostonGene Tumor Portrait test, the study aims to identify actionable findings, assess feasibility, and determine patient enrollment in clinical trials. Four cohorts of 100 patients each will be studied over two years, focusing on treatment decisions and patient outcomes. This study seeks to demonstrate the clinical utility of genomic testing in guiding therapy for advanced cancer patients in community settings. conditions: Breast Cancer conditions: Non-small Cell Lung Cancer conditions: Melanoma conditions: Sarcoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 400 type: ESTIMATED measure: Frequency of actionable findings measure: Test turn-around time measure: Frequency of patients who receive molecularly matched therapy measure: Frequency of patients who receive molecularly matched therapy sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Northwest Medical Specialities city: Puyallup state: Washington zip: 98373 country: United States name: Sibel Blau, MD role: CONTACT lat: 47.18538 lon: -122.2929 hasResults: False
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<|newrecord|> nctId: NCT06272851 id: Choroidal thickness by OCT briefTitle: Measuring Choroidal Thickness Using Optical Coherence Tomography overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2029-03-30 date: 2029-05-15 date: 2024-02-22 date: 2024-02-22 name: Assiut University class: OTHER briefSummary: To compare the choroidal thickness in eyes of diabetic patients with eyes of age matched controls using optical coherence tomography. conditions: Choroid Disease conditions: Diabetes Mellitus studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 122 type: ESTIMATED name: optical coherence tomography measure: comparison between choroidal thickness sex: ALL minimumAge: 30 Years maximumAge: 95 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06272838 id: 2023-19/145 briefTitle: Biodex Balance System in Patients With Parkinson's Disease overallStatus: RECRUITING date: 2024-02-28 date: 2024-09-14 date: 2024-10-14 date: 2024-02-22 date: 2024-02-22 name: Kirsehir Ahi Evran Universitesi class: OTHER briefSummary: Conventional balance exercises are an effective rehabilitation method applied in routine rehabilitation programs for Parkinson's patients. With technological developments, balance exercises conditions: Parkinson Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomised controlled primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Investigator and Outcomes Assessor will be different persons whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Biodex balance system name: The conventional balance exercise program measure: Berg Balance Scale measure: Berg Balance Scale measure: Berg Balance Scale measure: Biodex dynamic balance score measure: Biodex dynamic balance score measure: Biodex dynamic balance score measure: The fall efficacy scale measure: The fall efficacy scale measure: The fall efficacy scale measure: Time up and go test measure: Time up and go test measure: Time up and go test measure: The 8-item version of the Parkinson's Disease Questionnaire (PDQ-8) measure: The 8-item version of the Parkinson's Disease Questionnaire (PDQ-8) measure: The 8-item version of the Parkinson's Disease Questionnaire (PDQ-8) measure: The Five Times Sit to Stand Test measure: The Five Times Sit to Stand Test measure: The Five Times Sit to Stand Test measure: Beck Depression Inventory measure: Beck Depression Inventory measure: Beck Depression Inventory sex: ALL minimumAge: 40 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kırşehir Ahi Evran University Faculty of Medicine status: RECRUITING city: Kırşehir state: City Center zip: 40100 country: Turkey name: Basak Cigdem Karacay, Asist Prof role: CONTACT phone: 0905445094803 email: [email protected] name: Basak Cigdem Karacay, Asist Prof role: PRINCIPAL_INVESTIGATOR lat: 39.14583 lon: 34.16389 hasResults: False
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<|newrecord|> nctId: NCT06272825 id: 2023-19/140 briefTitle: Virtual Reality in Patients With Knee Osteoarthritis overallStatus: RECRUITING date: 2024-02-28 date: 2024-07-14 date: 2024-08-14 date: 2024-02-22 date: 2024-02-22 name: Kirsehir Ahi Evran Universitesi class: OTHER briefSummary: One of the main challenges facing the therapist in the treatment of adhesive capsulitis is to motivate the patient throughout conventional therapy. As noted in a recent review, individuals are more interested in leisure activities rather than performing repetitive tasks during therapy. Virtual reality (VR) is a three-dimensional computer-aided programme built with a system that creates virtual reality movements and generates a high amount of visual and sensory feedback during exercise. As a result, virtual reality (VR) has been used in many medical indications and has been shown to promote adherence to treatment by increasing patient motivation. conditions: Knee Osteoarthritis conditions: Pain conditions: Quality of Life studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomised controlled primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Investigator and Outcomes Assessor will be different persons. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Virtual reality name: conventional rehabilitation measure: Visual Analog Scale measure: Visual Analog Scale measure: Visual Analog Scale measure: The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) measure: The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) measure: The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) measure: Biodex Balance System measure: Biodex Balance System measure: Biodex Balance System measure: Short Form 36 (SF36) measure: Short Form 36 (SF36) measure: Short Form 36 (SF36) sex: ALL minimumAge: 40 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kırşehir Ahi Evran University Faculty of Medicine status: RECRUITING city: Kırşehir state: City Center zip: 40100 country: Turkey name: Basak Cigdem Karacay, Asist Prof role: CONTACT phone: 0905445094803 email: [email protected] name: Basak Cigdem Karacay, Asist Prof role: PRINCIPAL_INVESTIGATOR lat: 39.14583 lon: 34.16389 hasResults: False
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<|newrecord|> nctId: NCT06272812 id: IAVI C113 briefTitle: A Study to Evaluate the Efficacy, Safety and Immunogenicity of MTBVAC in IGRA Positive Adolescents and Adults Living in a TB Endemic Region. overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2028-03 date: 2028-03 date: 2024-02-22 date: 2024-02-22 name: International AIDS Vaccine Initiative class: NETWORK name: Biofabri, SLU name: Universidad de Zaragoza briefSummary: A Phase 2b, double-blind, randomized, placebo-controlled study to evaluate the efficacy, safety and immunogenicity of a candidate tuberculosis (TB) vaccine, MTBVAC, against TB disease in interferon gamma release assay positive adolescents and adults aged 14-45 years, living in a TB endemic region. conditions: Tuberculosis (TB) studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE maskingDescription: Double blind whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 4300 type: ESTIMATED name: MTBVAC name: Placebo measure: To evaluate the protective efficacy of of MTBVAC against bacteriologically confirmed pulmonary TB disease, diagnosed by more than one diagnostic test with sputum obtained before initiation of TB treatment as compared to placebo. measure: To evaluate the protective efficacy of one dose of MTBVAC against bacteriologically confirmed pulmonary TB disease, not associated with HIV infection, diagnosed with sputum obtained before initiation of TB treatment, as compared to placebo. measure: To evaluate the protective efficacy of MTBVAC candidate vaccine against definite Xpert MTB/RIF Ultra positive pulmonary TB disease diagnosed with sputum obtained before initiation of TB treatment, as compared to placebo. measure: To evaluate the protective efficacy of one dose of MTBVAC candidate vaccine against clinical TB, as compared to placebo measure: To assess the safety and reactogenicity of one dose of MTBVAC candidate vaccine. measure: To assess the safety and reactogenicity of one dose of MTBVAC candidate vaccine. measure: To assess the safety and reactogenicity of one dose of MTBVAC candidate vaccine. measure: To assess the safety and reactogenicity of one dose of MTBVAC candidate vaccine. measure: To assess the safety and reactogenicity of one dose of MTBVAC candidate vaccine. measure: To assess the safety and reactogenicity of one dose of MTBVAC candidate vaccine. measure: To assess the immunogenicity of one dose of the MTBVAC candidate vaccine via assessment of humoral and cell-mediated immune (CMI) responses in a subset of the enrolled participants. measure: To assess the immunogenicity of one dose of the MTBVAC candidate vaccine via assessment of humoral and cell-mediated immune (CMI) responses in a subset of the enrolled participants. sex: ALL minimumAge: 14 Years maximumAge: 45 Years stdAges: CHILD stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06272799 id: RS1480/21 briefTitle: Tolerability and Efficacy of Adjuvant T-DM1 in Patients With HER2 Positive Breast Cancer After Incomplete Pathological Response to Neoadjuvant Chemotherapy Including Anti-HER2 Agents. Real-world Multicenter Retrospective-prospective Study acronym: ATD overallStatus: RECRUITING date: 2022-09-20 date: 2024-09-20 date: 2024-09-20 date: 2024-02-22 date: 2024-02-22 name: Regina Elena Cancer Institute class: OTHER briefSummary: Multicenter, retrospective-prospective, real-world observational study, with the aim of evaluating tolerability and efficacy in a population of patients treated according to clinical practice outside of studies randomized. conditions: Breast Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 160 type: ESTIMATED name: T-DM1 adjuvant measure: Evaluate the tolerability. measure: Evaluate the effectiveness of treatment. sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: "Regina Elena" National Cancer Institute status: RECRUITING city: Rome zip: 00144 country: Italy name: Patrizia Vici, Doctor role: CONTACT phone: 06-5266.5584 phoneExt: +39 email: [email protected] lat: 41.89193 lon: 12.51133 hasResults: False
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<|newrecord|> nctId: NCT06272786 id: 2023-18/128 briefTitle: Suprascapular Nerve Block in Patients Rehabilitated After Arthroscopic Rotator Cuff Repair overallStatus: RECRUITING date: 2024-02-28 date: 2024-09-01 date: 2024-10-01 date: 2024-02-22 date: 2024-02-22 name: Kirsehir Ahi Evran Universitesi class: OTHER briefSummary: Suprascapular nerve block is an injection method that has been shown to be effective in shoulder rehabilitation in diseases such as adhesive capsulitis and stroke .. Applying the block under USG guidance instead of blinding increases the effectiveness and reduces complications. conditions: Rotator Cuff Tears conditions: Pain conditions: Nerve Block studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomised controlled primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Investigator and outcome assessor will be different persons. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 36 type: ESTIMATED name: conventional physiotherapy program. name: Suprascapular nerve block measure: Visual Analog Scale (VAS) measure: Visual Analog Scale (VAS) measure: Visual Analog Scale (VAS) measure: Shoulder joint range of motion (ROM) measure: Shoulder joint range of motion (ROM) measure: Shoulder joint range of motion (ROM) measure: Shoulder Pain and Disability İndex (SPADİ) measure: Shoulder Pain and Disability İndex (SPADİ) measure: Shoulder Pain and Disability İndex (SPADİ) measure: Modified Constant-Murley Scoring measure: Modified Constant-Murley Scoring measure: Modified Constant-Murley Scoring sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ahi Evran University status: RECRUITING city: Kirşehir state: City Centre zip: 40100 country: Turkey name: Basak Cigdem Karacay, Assist Prof role: CONTACT phone: :+90 386 280 39 00 email: [email protected] name: Basak Cigdem Karacay, Assist Prof role: PRINCIPAL_INVESTIGATOR lat: 39.14583 lon: 34.16389 hasResults: False
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<|newrecord|> nctId: NCT06272773 id: IRAS Ref: 333663 briefTitle: Forced Oscillation and Breathing Pattern in Asthma overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-10 date: 2025-03 date: 2024-02-22 date: 2024-02-22 name: Karl Sylvester class: OTHER briefSummary: Asthma is a chronic respiratory disease characterised by airway inflammation, bronchoconstriction, and airway hyperresponsiveness. Accurate and reliable assessment of lung function is crucial in diagnosing and monitoring asthma. The forced oscillation technique (FOT) is a non-invasive method that has gained attention in recent years as a valuable tool for evaluating respiratory mechanics in asthma.
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FOT involves applying small amplitude oscillations at various frequencies to the respiratory system and measuring the resulting pressure and flow responses. These measurements provide valuable insights into the mechanical properties of the airways, including resistance, compliance, and reactance. FOT offers several advantages over traditional spirometry, such as its ability to assess peripheral airway function, sensitivity to small airway abnormalities, and ease of use, particularly in young children or individuals with severe airflow limitation. FOT also allows for assessment of respiratory mechanics in individuals who may struggle with performing spirometry manoeuvres.
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However, it is unclear whether a change in breathing pattern in patients with obstructive lung disease impacts the assessment of a response to treatment utilising FOT.
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Several studies have demonstrated a high prevalence of Breathing Pattern Disorders (BPDs) in individuals with asthma. These findings suggest that BPDs may be common in asthma and could contribute to the manifestation and severity of respiratory symptoms. Evidence suggests that BPDs can adversely affect pulmonary function in individuals with asthma. One study demonstrated that children with asthma and dysfunctional breathing exhibited significantly reduced forced expiratory volume in one second (FEV1) compared to asthmatics without BPD. This suggests that abnormal breathing patterns may contribute to airflow limitation in asthma, leading to decreased lung function.
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We therefore wish to determine the impact of different breathing frequencies on parameters measured using FOT in patients diagnosed with asthma and concomitant obstructive lung function abnormality. conditions: Asthma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 65 type: ESTIMATED name: Forced Oscillation Test measure: Change in airway resistance at 5 Hertz (Hz) and 19Hz sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06272760 id: 2024-02-060 briefTitle: Development of a Remote Therapy Protocol for Upper Limb Function Enhancement in Children With Cerebral Palsy overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-09-30 date: 2026-02-28 date: 2024-02-22 date: 2024-02-22 name: Samsung Medical Center class: OTHER briefSummary: The perpose of this study: Development and demonstration of a teletherapy protocol to improve upper limb function in children with cerebral palsy. conditions: Cerebral Palsy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized Controlled Trial primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Single blinding whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Home-based hand-arm bimanual intensive training (Tele-HABIT) name: Hand-arm bimanual intensive training (In-clinic-HABIT) measure: Change from Assisting Hand Assessment (AHA) score at post-intervention test (T1-T0). measure: Change from Baseline Pediatric Motor Activity Log (PMAL) score at post-intervention test (T1-T0). measure: Change from Baseline Melbourne Assessment 2 (MA2) score at post-intervention test (T1-T0). measure: Change from Canadian Occupational Performance Measure (COPM) score at post-intervention test (T1-T0). measure: Change from Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT) score at post-intervention test (T1-T0). measure: Change from baseline Magnitude ratio (Accelerometer) at post-intervention test (T1-T0). measure: Change from baseline Bilateral magnitude(Accelerometer) at post-intervention test (T1-T0). sex: ALL minimumAge: 6 Years maximumAge: 12 Years stdAges: CHILD hasResults: False
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<|newrecord|> nctId: NCT06272747 id: XH-S003-I-101 briefTitle: A Phase I Study of XH-S003 in Healthy Volunteers overallStatus: NOT_YET_RECRUITING date: 2024-02-22 date: 2024-07-30 date: 2024-10-30 date: 2024-02-22 date: 2024-02-22 name: S-Infinity Pharmaceuticals Co., Ltd class: INDUSTRY briefSummary: The purpose of the study is to assess the safety, tolerability and pharmacokinetics of XH-S003 in healthy volunteers under SAD (Single ascending dose) and MAD (Multiple ascending dose) studies. In addition, this study evaluates the food effects of XH-S003. conditions: Healthy Adults studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 44 type: ESTIMATED name: XH-S003 name: Placebo measure: Number of participants with adverse events (AEs) measure: Number of participants with adverse events (AEs) sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Beijing Friendship Hospital,Capital Medical University city: Beijing country: China name: Ruihua Dong, MD role: CONTACT phone: 010-63139033 email: [email protected] lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06272734 id: RCV-0007 briefTitle: Reprieve System Pilot Study overallStatus: RECRUITING date: 2024-01-23 date: 2024-12-31 date: 2025-01-31 date: 2024-02-22 date: 2024-02-22 name: Reprieve Cardiovascular, Inc class: INDUSTRY briefSummary: The objective of the study is to evaluate the use of the Reprieve System to decongest subjects with acute decompensated heart failure. conditions: Acute Decompensated Heart Failure studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Reprieve System measure: Functional Device Success sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tbilisi Heart and Vascular Clinic status: RECRUITING city: Tbilisi zip: 0159 country: Georgia name: Tamaz Shaburishvili, MD role: CONTACT phone: +995 322 479300 email: [email protected] lat: 41.69411 lon: 44.83368 hasResults: False
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<|newrecord|> nctId: NCT06272721 id: 6272 briefTitle: Hypothyroidism in Pregnancy and Neuropsychological Development in Children acronym: OHPLDO overallStatus: NOT_YET_RECRUITING date: 2024-02-19 date: 2024-04-30 date: 2024-05-31 date: 2024-02-22 date: 2024-02-22 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER briefSummary: Thyroid dysfunction, particularly hypothyroidism and thyroid autoimmunity, impacts a significant proportion of pregnant women, affecting 3% and 17% respectively. The management of thyroid-stimulating hormone (TSH) levels is crucial, with subclinical hypothyroidism often defined by a TSH upper reference limit of 4 mU/L, and overt hypothyroidism by TSH levels above 10 mU/L and potentially low free thyroxine (FT4) levels. Levothyroxine (LT4) treatment is strongly advised for TSH levels above 10 mU/L, with the timing of intervention being critical during the first trimester for optimal fetal brain development.
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Research shows that untreated maternal hypothyroidism can significantly impact the neuropsychological development of the child, affecting cognitive, verbal, and motor skills. Even subclinical maternal hypothyroidism has been associated with lower IQ and motor scores in children. Early pregnancy intervention is key, as treatment after the first trimester may not improve children's neurocognitive outcomes.
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Regarding sensory and linguistic development, evidence is mixed, but recent studies suggest that maternal hypothyroidism can lead to expressive language delays. The Development Quotient (DQ) is used to assess cognitive and motor development in children, with the Griffiths Mental Development Scales II being a common tool.
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This study aims to explore the effects of treated maternal hypothyroidism during pregnancy on children's neurodevelopment, focusing on learning and language. It includes 31 women diagnosed with hypothyroidism and a control group of 21 euthyroid women, along with their children. The study emphasizes the importance of early detection and treatment of maternal hypothyroidism for preventing adverse neurodevelopmental outcomes in offspring. Statistical analysis will be conducted using SPSS, with a focus on maternal-fetal outcomes and cognitive-neuropsychological outcomes, highlighting the significance of early intervention. conditions: Thyroid Dysfunction conditions: Pregnancy Related conditions: Language Development studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 104 type: ESTIMATED name: Griffiths Scale measure: total development quotient measured using the Griffiths scale sex: ALL minimumAge: 2 Years maximumAge: 50 Years stdAges: CHILD stdAges: ADULT facility: Fondazione Policlinico Universitario A. Gemelli IRCCS city: Roma zip: 00168 country: Italy name: ALFREDO PONTECORVI role: CONTACT phone: +390630155701 email: [email protected] name: ALFREDO PONTECORVI role: PRINCIPAL_INVESTIGATOR lat: 41.89193 lon: 12.51133 hasResults: False
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<|newrecord|> nctId: NCT06272708 id: IIT-2023-0356 briefTitle: Preliminary Exploration of Thromboelastography in the Monitoring of Anticoagulation in Maintenance Hemodialysis Patients overallStatus: RECRUITING date: 2024-01-29 date: 2024-02-29 date: 2024-05-31 date: 2024-02-22 date: 2024-02-22 name: RenJi Hospital class: OTHER briefSummary: Objectives: To investigate the role of thromboelastography parameters (R, K, Angle, MA) in monitoring anticoagulation in maintenance hemodialysis (MHD) patients.
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Subjects: Two hundred stable MHD patients. Methods: An observational study. Primary outcome: Relationship between thromboelastography parameter R Value and coagulation of hemodialysis circuit and dialyzer.
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Secondary outcome: Relationship between thromboelastography parameters (K Value, Angle and MA) and coagulation of hemodialysis circuit and dialyzer. conditions: Thromboelastography conditions: Hemodialysis conditions: Anticoagulation studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 200 type: ESTIMATED measure: thromboelastography parameter R value measure: thromboelastography parameter K value measure: thromboelastography parameter Angle measure: thromboelastography parameter MA sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Renji Hospital, School of Medicine, Shanghai Jiao Tong University status: RECRUITING city: Shanghai state: Shanghai zip: 200127 country: China name: Yunyue Guo role: CONTACT phone: 0086-021-68383312 email: [email protected] lat: 31.22222 lon: 121.45806 hasResults: False
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<|newrecord|> nctId: NCT06272695 id: R477-203 briefTitle: Glucagon Rescue of Insulin-Induced Hypoglycemia in Adults With Type 1 Diabetes Treated With Volagidemab overallStatus: RECRUITING date: 2024-02-15 date: 2025-06-15 date: 2025-06-15 date: 2024-02-22 date: 2024-04-10 name: REMD Biotherapeutics, Inc. class: INDUSTRY briefSummary: This trial is designed to evaluate the effect of glucagon receptor antagonism by volagidemab (once weekly) on glucose recovery from hypoglycemia after treatment with glucagon in adults with type 1 diabetes. After informed consent, Screening procedures to establish subject eligibility will be performed within a period of 28 days. Approximately 24 subjects with type 1 diabetes mellitus (T1DM) on stable doses of insulin will be enrolled.
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After enrollment, subjects will undergo a baseline Hypoglycemia Recovery Procedure (with glucagon rescue). Subjects will then receive volagidemab subcutaneously (SC) once weekly for 6 weeks. At the end of the treatment phase, subjects will undergo a second Hypoglycemia Recovery Procedure. Subjects will be followed for 6 weeks after the last volagidemab dose with a final End-of-Study (EOS) visit during Week 12. The primary outcome will be the change in time to glucagon treatment success at Week 6 versus baseline. conditions: Type 1 Diabetes Mellitus studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: Volagidemab measure: Change in Time to glucagon treatment success at Week 6. measure: Blood glucose response to glucagon rescue treatment during insulin-induced hypoglycemia. measure: Treatment emergent adverse events (AEs) measure: Hypoglycemia symptoms - Edinburgh Hypoglycemia Scale measure: Hypoglycemia symptoms - Clarke Survey measure: Hypoglycemia symptoms - Gold Questionnaire measure: Change from baseline in hemoglobin A1c (HbA1c) at Week 6. sex: ALL minimumAge: 18 Years maximumAge: 72 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Altman Clinical and Translational Research Institute status: NOT_YET_RECRUITING city: San Diego state: California zip: 92037 country: United States name: Schafer Boeder, MD role: CONTACT name: Schafer Baoder, MD role: PRINCIPAL_INVESTIGATOR lat: 32.71533 lon: -117.15726 facility: Diablo Clinical Research status: RECRUITING city: Walnut Creek state: California zip: 94598 country: United States name: Mark Christiansen, MD role: CONTACT email: [email protected] name: Mark Christiansen, MD role: PRINCIPAL_INVESTIGATOR lat: 37.90631 lon: -122.06496 hasResults: False
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<|newrecord|> nctId: NCT06272682 id: 6669 briefTitle: Corticosteroids in Carpal Tunnel Syndrome. Prospective Randomised Controlled Non-inferiority Study overallStatus: RECRUITING date: 2023-07-17 date: 2024-08-11 date: 2025-10-11 date: 2024-02-22 date: 2024-02-22 name: Hospital Italiano de Buenos Aires class: OTHER briefSummary: The goal of this prospective, randomised, controlled, non-inferiority analytical study is to compare the Boston score in patients treated with systemic (intramuscular) versus local infiltration corticosteroids in mild and moderate carpal tunnel syndrome in patients over 18 years of age with mild or moderate carpal tunnel syndrome.
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The main questions it aims to answer are:
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* What is the effectiveness of intramuscular injection of corticosteroids compared to local infiltration in the treatment of mild/moderate carpal tunnel syndrome?
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* What are the adverse effects and application site pain associated with each route of administration?
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Patients who meet the inclusion criteria will be asked to participate in the study and sign an informed consent form.
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The Redcap randomizer will be used to assign the patient to one of the branches.
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Researchers will compare
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* Branch A: patients treated with local corticosteroid infiltration in carpal tunnel under ultrasound
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* Branch B: patients treated with intramuscular corticosteroid injection.
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Researchers will:
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* Compare Boston Carpal Tunnel Questionnaire score at 1.5 months, 3 months, 6 months and 12 months post-procedure.
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* Describe adverse reactions associated with the route of administration.
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* Compare the pain at the site of application associated with the route of administration. conditions: Carpal Tunnel Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Prospective, randomised, controlled, non-inferiority analytical study primaryPurpose: TREATMENT masking: NONE count: 106 type: ESTIMATED name: Systemic bethametasone injection name: Local bethametasone injection measure: Compare the Boston Carpal Tunnel Syndrome Questionnaire measure: Adverse reactions measure: Pain at the site of application sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Italiano de Buenos Aires status: RECRUITING city: Buenos Aires zip: C1199 country: Argentina name: Jorge Boretto, MD role: CONTACT phone: +541169026969 email: [email protected] name: Rocio Avanzi, MD role: CONTACT phone: +541157727055 email: [email protected] lat: -34.61315 lon: -58.37723 hasResults: False
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<|newrecord|> nctId: NCT06272669 id: HSEARS20220216004 briefTitle: Cumulative and Booster Effects of Multisession Prefrontal tDCS in Adolescents With ASD overallStatus: RECRUITING date: 2022-06-02 date: 2025-09 date: 2025-12 date: 2024-02-22 date: 2024-02-22 name: The Hong Kong Polytechnic University class: OTHER briefSummary: Autism spectrum disorder (ASD) is a neurodevelopmental disorder characterized by disturbances in communication, poor social skills, and aberrant behavior. To date, ASD has no known cure, and the disorder remains a highly disabling condition. Recently, transcranial direct-current stimulation (tDCS), a non-invasive brain stimulation technique, has shown great promise as a potentially effective and cost-effective tool for reducing the core symptoms in patients with autism, such as anxiety, aggression, impulsivity, and inattention. Although the preliminary findings in patients with ASD are encouraging, it remains to be determined whether this experimental data can translate into benefits in real life. Further studies are needed to determine the factors that can lengthen the therapeutic effects or cognitive benefits of tDCS, and to determine possible risk factors associated with relapse in patients with ASD. Booster sessions of tDCS is an important component of treatment planning and prognosis and may promote better outcomes to control for resurgence of symptoms. This study has three aims. First, the investigators aim to evaluate the therapeutic effects of tDCS on improving cognitive function in patients with ASD. Second, the investigators aim to better understand the neural mechanisms underlying the neuro-enhancing effects of tDCS in patients with ASD. Third, the investigators aim to assess the effectiveness of booster treatment cycles of tDCS for enhancing cognitive and social functions in individuals with ASD. conditions: Transcranial Direct Current Stimulation conditions: Autistic Spectrum Disorder conditions: Electroencephalography studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: This study comprises 3 phases: Phase 1 will be a randomized controlled trial in which 90 participants will be randomly assigned to receive either active or sham-tDCS combined with computerized executive function training for 10 consecutive working days over 2 weeks period. The other 2 phases will be an open-label, crossover phase, in which for Phase 2, participants in the sham-tDCS group will receive 10-day active tDCS and assessments will be performed before and after the 10-tDCS session. Whereas bimonthly booster tDCS sessions will be provided to all tDCS responders for the first 3 months and monthly booster tDCS in the subsequent 3 months (Total 9 sessions in phase 3), and with assessments performed every month in Phase 3. primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 90 type: ESTIMATED name: Active-tDCS name: Sham-tDCS measure: Change in social responsiveness - Social Responsiveness Scale-2nd edition (SRS-2) measure: Clinical response in tDCS outcome measure: Change in neuropsychological measures - CANTAB® cognitive tests sex: ALL minimumAge: 12 Years maximumAge: 21 Years stdAges: CHILD stdAges: ADULT facility: The Hong Kong Polytechnic University status: RECRUITING city: Hung Hom state: Kowloon zip: Hong Kong country: Hong Kong name: Yvonne Han, PhD role: CONTACT phone: +852 27667578 email: [email protected] lat: 22.30715 lon: 114.18532 hasResults: False
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<|newrecord|> nctId: NCT06272656 id: AKR-TACE-001 briefTitle: Evaluation of AKR1B10 as a New Marker for Interventional Therapy of Hepatocellular Carcinoma overallStatus: RECRUITING date: 2024-04-01 date: 2025-06-30 date: 2025-06-30 date: 2024-02-22 date: 2024-04-03 name: Hebei Medical University Third Hospital class: OTHER briefSummary: Primary liver cancer is currently the fourth most common malignant tumor and the second leading cause of tumor mortality in China, posing a serious threat to the lives and health of the Chinese people . At present, non-surgical treatment methods are often used, such as radiofrequency ablation (RFA), Transcatheter arterial chemoembolization (TACE), radiation therapy, and systemic anti-tumor therapy. However, whether it is surgical treatment or non-surgical treatment, commonly used liver cancer related biomarkers in clinical practice during the evaluation of treatment efficacy or regular follow-up of patients include AFP, AFP-L3%, DCP, etc. , but there are no reports on whether AKR1B10 can be used for the efficacy evaluation of these treatment methods.Therefore, this project aims to explore the clinical value of AKR1B10 in evaluating the efficacy of liver cancer treatment. conditions: Hepatocellular Carcinoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED measure: comparison of liver cancer markers AKR1B10, AFP, AFP-L3% and DCP before and after TACE measure: long-term survival (1-year, 3-year, 5-year) measure: progression- free - time sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: HebeiMUTH status: RECRUITING city: Shijia Zhuang state: Hebei zip: 050000 country: China name: Yuemin Nan role: CONTACT phone: +8633188602489 email: [email protected] name: Pei Guo role: CONTACT phone: 17835683894 email: [email protected] lat: 34.17775 lon: 109.84894 typeAbbrev: Prot_ICF hasProtocol: True hasSap: False hasIcf: True label: Study Protocol and Informed Consent Form date: 2023-12-25 uploadDate: 2024-02-02T21:48 filename: Prot_ICF_000.pdf size: 258859 hasResults: False
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<|newrecord|> nctId: NCT06272643 id: EPIC36-EMPERATRIZ briefTitle: Comparison Between Optical Coherence Tomography and Intravascular Ultrasound for Intermediate Left Main Coronary Artery Lesions acronym: EMPERATRIZ overallStatus: RECRUITING date: 2024-04-04 date: 2025-01-20 date: 2026-01-20 date: 2024-02-22 date: 2024-04-09 name: Fundación EPIC class: OTHER briefSummary: Significant coronary disease of the left main coronary artery (LMCA) is found in 4%-5% of all coronary angiography procedures. Classically, it has been determined that a significant angiographic stenosis should reach at least 50% of the vessel diameter by visual estimation, which corresponds to 75% of the vessel area. However, angiography has a number of limitations inherent to the technique and location of stenosis, and other techniques are therefore available for evaluation. Intracoronary ultrasound (IVUS) deserves, together with the pressure guidewire, special consideration in determining the severity assessment (anatomical and functional) of lesions in this location. Using IVUS the most commonly used cut-off value is 6 mm2. in ambiguous lesions of the LMCA, a MLA \>6 mm2 would indicate no revascularisation, a MLA \<4.5-5 mm2 would indicate revascularisation, and MLA values between 4.5-5 and 6 mm2 would make it advisable to use FRF/iFR to decide. Optical coherence tomography (OCT) is another intracoronary imaging modality, with greater resolution and significant differences from IVUS. no MLA cut-off point with OCT has been demonstrated for the management of LMCA lesions. Due to the differences in imaging with both techniques, the thresholds established as cut-off points in IVUS cannot be extrapolated to OCT. The objective is to compare the minimal luminal area by IVUS and OCT of angiographically intermediate LCMA lesions and to assess the prognostic value of TCFA assessed by OCT. conditions: Coronary Disease studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 129 type: ESTIMATED name: IVUS (Intravascular Ultrasound) and OCT (Optical Coherence Tomography) measure: To assess the agreement between minimum luminal area measured by IVUS and OCT in intermediate LCMA lesions measure: Cardiac Death measure: Cardiovascular Death measure: Acute myocardial infarction of treated/functionally assessed lesion measure: Acute myocardial infarction of any lesion measure: Need for revascularisation of lesion treated/functionally assessed measure: Need for revascularisation of any lesion measure: Secondary efficacy endpoint: Clear Image Length measure: Extend of detectable EEL in LM measure: Correlation between contrast volume used and results, as well as the average contrast volume used in the study. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Universitario Juan Ramon Jimenez status: RECRUITING city: Huelva zip: 21005 country: Spain lat: 37.26638 lon: -6.94004 facility: Hospital Universitario de Leon status: RECRUITING city: León zip: 24071 country: Spain lat: 42.60003 lon: -5.57032 hasResults: False
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<|newrecord|> nctId: NCT06272630 id: DW_DWJ1464401 briefTitle: Study to Evaluate the Efficacy and Safety of DWJ1464 in Patients With Chronic Liver Disease overallStatus: ENROLLING_BY_INVITATION date: 2023-02-06 date: 2024-05-31 date: 2024-08-31 date: 2024-02-22 date: 2024-04-26 name: Daewoong Pharmaceutical Co. LTD. class: INDUSTRY briefSummary: This study aims to assess the effect of DWJ1464 on improvement of liver function in patients with Chronic liver disease. Patients with Chronic liver disease aged 19 years or over will participate in the study. The study design is a multi-center double-blinded randomized placebo-controlled trial. The patients were diagnosed with Chronic liver disease based on our criteria and were randomized to either the placebo or DWJ1464 administration group. Primary endpoint was the change of ALT level after 8 weeks compared to the baseline. Secondary endpoints included the change of ALT level after 4 weeks, the change rate of ALT level after 8 weeks and improvement of fatigue, compared to the baseline. the adverse effect of DWJ1464 were also recorded. conditions: Chronic Liver Disease studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 258 type: ESTIMATED name: DWJ1464 name: Placebo of DWJ1464 measure: At 8 weeks, the change of ALT level compared to baseline measure: At 4 weeks, the change of ALT level compared to baseline measure: At 4, 8 weeks, the change of AST level compared to baseline measure: At 4, 8 weeks, the change of liver function comparator GGT level compared to baseline measure: At 8 weeks, the change of liver function comparator Fibrotest compared to baseline measure: At 8 weeks, the change of liver function comparator Fibroscan compared to baseline measure: At 4, 8 weeks, the change of K-CFQ(Korean version of Chalder Fatigue Scale) scores, compared to the baseline sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: SoonChunHyang University Seoul Hospital city: Seoul zip: 04401 country: Korea, Republic of lat: 37.566 lon: 126.9784 hasResults: False
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<|newrecord|> nctId: NCT06272617 id: 2023-960 briefTitle: Acupuncture for Prevention and Treatment of Oral-related Complications Caused by Radiotherapy for Head and Neck Cancer overallStatus: RECRUITING date: 2023-07-25 date: 2024-07-24 date: 2025-07-24 date: 2024-02-22 date: 2024-02-22 name: West China Hospital class: OTHER name: West China Fourth Hospital, Sichuan University briefSummary: A study on the efficacy and safety of acupuncture for the prevention and treatment of oral-related complications caused by radiotherapy for head and neck malignant tumors conditions: Malignant Tumor of Head and/or Neck conditions: Radiotherapy; Complications studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 138 type: ESTIMATED name: verum acupuncture name: sham acupuncture measure: Xerostomia questionnaire scores measure: Salivary flow rate measure: Taste function assessed by patients measure: Taste function assessed by electrogustometer test measure: Taste function assessed by taste strips test measure: Oral mucositis measure: Dysphagia measure: Quality of Life assessed by EORTC QLQ-C30 measure: Quality of Life assessed by QLQ-H&N35 measure: Adverse effects measure: Changes of oral flora measure: Tongue range of motion measure: Neck Fibrosis sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: West China Hospital, Sichuan University status: RECRUITING city: Chengdu state: Sichuan country: China name: Xingchen Peng role: CONTACT phone: 0086-18980606753 email: [email protected] lat: 30.66667 lon: 104.06667 hasResults: False
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<|newrecord|> nctId: NCT06272604 id: 2024-IRB-0015-P-01 briefTitle: Exercise Rehabilitation for Children With Asthma overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2027-04-01 date: 2027-10-01 date: 2024-02-22 date: 2024-02-22 name: The Children's Hospital of Zhejiang University School of Medicine class: OTHER briefSummary: Asthma, a prevalent chronic condition among children and adolescents, substantially impairs their quality of life. In addressing this significant health concern, this study focuses on the potential of a customized exercise rehabilitation program tailored for this young demographic. By employing a randomized controlled trial design, the research aims to divide participants into two distinct groups: one undergoing a personalized exercise regimen and the other receiving standard medical care. The 12-week intervention for the exercise group includes a combination of aerobic activities, strength training, and targeted breathing exercises. The study's primary aim is to rigorously evaluate the impact of this specialized exercise protocol on critical health aspects such as lung function, physical endurance, frequency of asthma attacks, and overall quality of life. The anticipated findings from this research are expected to shed new light on effective asthma management strategies and offer invaluable guidance for clinical practices dedicated to improving health outcomes in young asthma patients. conditions: Asthma in Children conditions: Rehabilitation conditions: Exercise studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Personalized Exercise Rehabilitation measure: Lung Function measure: Daily Physical Activity Level measure: Asthma Control Status measure: Fractional Exhaled Nitric Oxide (FeNO) measure: Body Composition measure: Sleep measure: Health Related Quality of Life measure: Anxiety and Depression measure: Inflammatory Mediators sex: ALL minimumAge: 6 Years maximumAge: 17 Years stdAges: CHILD hasResults: False
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<|newrecord|> nctId: NCT06272591 id: IRBN1192023/CHUSTE briefTitle: Comparison of Patient Satisfaction With Home Induction and In-patient Induction. overallStatus: RECRUITING date: 2023-11-20 date: 2024-05 date: 2024-05 date: 2024-02-22 date: 2024-02-22 name: Centre Hospitalier Universitaire de Saint Etienne class: OTHER briefSummary: Induced labour is a medical intervention designed to initiate or accelerate the childbirth process when clinically indicated.
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Induced labour concerns 25.8% of pregnant women in France, according to the latest National Perinatal Survey 2021. This rate is rising steadily, since in 2016 induction concerned 22% of pregnancies. There are many medical indications for induction, both maternal and foetal. Induced labour in hospitals is beginning to reach its limits, given the reduction in the number of nursing staff and the reduction in the number of beds available. In some cases, patients are hospitalised for 24 to 72 hours before going into labour. In this context, the place where the birth takes place, whether at home or in hospital, is essential, with a potential impact on patient satisfaction and the experience of induction.
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Cervical ripening can be a difficult experience for women, with a feeling of loss of control at this crucial stage. The duration of induction is one of the factors that women would like to see changed when asked about the aftermath of induction. The option of inducing at home might seem to improve women's experience and reduce the length of their stay in hospital. conditions: Induced; Birth conditions: Pregnancy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Preliminary search in the patient's file name: A posteriori research in the patient's file name: First questionnaire : choice of induction method reason for choice name: Second questionnaire : experience of induction measure: Questionnaire on patients' experience of induction in hospital and at home. measure: Questionnaire on patients' satisfaction of induction in hospital and at home. measure: Questionnaire on patients' choice of induction method measure: Questionnaire on reasons for choosing home induction. measure: Maternal morbidity measure: Maternal mortality measure: Neonatal morbidity measure: Neonatal mortality sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chu Saint Etienne status: RECRUITING city: St Etienne zip: 42100 country: France name: Tiphaine BARJAT, MD PhD role: CONTACT phone: (0)477828609 phoneExt: +33 email: [email protected] name: Clara CHIARADONNA, resident role: CONTACT phone: (0)634100341 phoneExt: +33 email: [email protected] name: Tiphaine BARJAT, MD PhD role: PRINCIPAL_INVESTIGATOR name: Clara CHIARADONNA, resident role: SUB_INVESTIGATOR lat: 45.43389 lon: 4.39 hasResults: False
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<|newrecord|> nctId: NCT06272578 id: 20021405 briefTitle: Screen CardRen - A Cross-sectional Observational Cohort Study overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-02-27 date: 2025-06-30 date: 2024-02-22 date: 2024-02-23 name: Charite University, Berlin, Germany class: OTHER name: AstraZeneca briefSummary: In this single-centre, cross-sectional study, the investigators aim to assess the prevalence of asymptomatic echocardiographic structural and functional cardiac abnormalities in adult CKD patients with additional cardiovascular risk factors. Furthermore, with the use of Olink technology, analyses of the plasma proteome will be performed to identify potential protein pathways associated with early structural changes.The investigators hypothesize that protein expression will be altered in patients with prevalent echocardiographic abnormalities that indicate stage B heart failure. conditions: Heart Failure conditions: Chronic Kidney Diseases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 400 type: ESTIMATED name: Echocardiography measure: prevalence of significant asymptomatic cardiac structural abnormalities and cardiac dysfunction measure: Proteomic analysis measure: Duration of echocardiographic examination measure: Time saved by portable echocardiography and automated image analysis measure: Image quality of cart-based vs. portable echo images sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06272565 id: 2023KYPJ292 briefTitle: Exploring the Interaction Between Metabolic Disorders and NLPR3 Inflammasome Activation in DR Inflammatory Damage acronym: DR overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2026-12-30 date: 2026-12-30 date: 2024-02-22 date: 2024-02-22 name: Zhongshan Ophthalmic Center, Sun Yat-sen University class: OTHER briefSummary: Diabetic retinopathy (DR) is one of the most serious microvascular complications of diabetes. Early diagnosis and treatment of diabetes is the key to prevent visual impairment in DR patients. This study aims to use a non-targeted metabolomics detection technique combined with ultra-high performance liquid chromatography time-of-flight mass spectrometry to analyze the metabolomics profile in aqueous humor sample of DR patents, and further explore the mechanism of the relationship between differential metabolites and their metabolic pathways with NLRP3 activation in DR inflammatory damage. DR patients with macular edema will receive anti-vascular endothelial growth factor (anti-VEGF) treatment; these patients will be divided into two groups: responders group and non-responders group. conditions: Diabetic Retinopathy conditions: Diabetic Macular Edema conditions: Anti-vascular Endothelial Growth Factor studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 240 type: ESTIMATED measure: Untargeted metabolomics for metabolic profile using UHPLC/MS measure: Best-corrected visual acuity measure: Central subfield thickness sex: ALL minimumAge: 40 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zhongshan Ophthalmic Center of Sun Yat-sen University city: Guangzhou state: Guangdong zip: 510623 country: China name: Zhongshan Ophthalmic Center of Sun Yat-sen University role: CONTACT phone: 86+13560323773 email: [email protected] lat: 23.11667 lon: 113.25 hasResults: False
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<|newrecord|> nctId: NCT06272552 id: PI21-00026 id: 2021/10182/I type: OTHER domain: CEIm Parc de Salut Mar briefTitle: Implementing PROMs and PREMs in Routine Clinical Care: Assessment of Requirements and Impact acronym: PROMs & PREMs overallStatus: RECRUITING date: 2023-10-25 date: 2027-10 date: 2027-10 date: 2024-02-22 date: 2024-02-22 name: Parc de Salut Mar class: OTHER name: Instituto de Salud Carlos III briefSummary: There has been increasing interest in the use of patient-reported outcomes and experience measures (PROMs and PREMs) in clinical practice; yet few empirical studies have been conducted to evaluate the usefulness of such implementation.
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Objective: To evaluate the efficacy of the implementation of PROMs and PREMs in routine clinical care for improving health outcomes and satisfaction with health management.
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Design: Randomized control trial. Setting: In and outpatient departments of a public hospital in Spain.
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